Table 2.

Summary of MLN8237-related DLTs during cycle 1, by dose and schedule

Dose and scheduleNumber of patients treatedNumber of patients with DLTsType and grade of DLTs
7-d schedule
 5 mg q.d.30
 10 mg q.d.30
 20 mg q.d.30
 40 mg q.d.30
 80 mg q.d.30
 110 mg q.d.61Somnolence, confusion, memory impairment (all grade 3)
 150 mg q.d.63Somnolence (grade 2), confusion (grade 2), stomatitis (grade 3), asthenia (grade 3), neutropenia (grade 4)
 50 mg b.i.d.112Febrile neutropenia (grade 4), thrombocytopenia (grade 4)
 60 mg b.i.d.62Febrile neutropenia (grade 4), thrombocytopenia (grade 4)
14-d schedule
 25 mg q.d.30
 40 mg b.i.d.22Diarrhea (grade 3), febrile neutropenia (grade 3), thrombocytopenia (grade 4)
21-d schedule
 25 mg q.d.30
 50 mg q.d.60
 70 mg q.d.71Diarrhea (grade 3), thrombocytopenia (grade 4), ventricular dysfunction (grade 3), neutropenia (grade 4)

Abbreviations: q.d., once daily; b.i.d., twice daily.